FDA application holder
Impax Laboratories Inc
The Orange Book identifies this organization as the applicant responsible for ANDA 073652.
Orange Book drug · Generic (ANDA)
Nitrofurantoin
Nitrofurantoin, Macrocrystalline
ANDA 073652 Impax Labs Inc
Approved
Jan 28, 1993
Strengths
1
Listed patents
0
Applications
29
What does the FDA Orange Book show for Nitrofurantoin?
Nitrofurantoin contains Nitrofurantoin, Macrocrystalline and appears in 29 FDA Orange Book applications. ANDA 073652 is the lead filing, with 1 presentation shown in detail; the other exact-name filings are listed separately. The page preserves strength, dosage form, route, status, RLD/RS, TE, patent, and exclusivity facts. Clinical labeling requires an exact application-matched source.
- FDA applications
- 29; lead ANDA 073652
- Lead application holder
- Impax Laboratories Inc
- Product presentations
- 1
- Marketing categories
- Prescription
- Reference roles
- None posted
- TE codes
- AB
- Listed patents
- 0
- Exclusivity records
- 0
Every filing shown uses the exact FDA product name; the lead filing supplies the detailed presentation view.
The listed applicant holds the FDA application; this field does not establish the product manufacturer.
Each FDA product number remains tied to its own strength, dosage form, route, and status.
Orange Book marketing categories do not establish real-time inventory or commercial availability.
RLD and RS designations are presentation-specific, not inferred from the trade name.
Therapeutic-equivalence codes apply only within the matching Orange Book product heading.
A zero means none appear in this snapshot, not that no patent rights exist.
FDA exclusivity and listed patent protection are distinct regulatory concepts.
Sourced from the official FDA Orange Book data file · snapshot refreshed
FDA product-presentation matrix
Every product number in this exact application
| Product | Strength | Dosage form / route | Marketing status | TE code | Reference role |
|---|---|---|---|---|---|
| 001 | 100MG | CAPSULEORAL | Prescription | AB | None posted |
Marketing status, TE code, RLD, and RS are presentation-level fields. Never transfer one product number's designation to another presentation.
Who is responsible for this application?
Application holder is not the same as manufacturer
Manufacturer status
Not established by the Orange Book
A product-specific FDA label or NDC source must independently identify a manufacturer, labeler, distributor, packager, repackager, or relabeler. The applicant name is not used as a substitute for that evidence.
Regulatory interpretation
What the record means, and what it does not
FDA marketing status
1 presentation listed as prescription
RX and OTC are Orange Book marketing categories, not real-time inventory signals. Confirm current commercial availability with labeling, the application holder, or an authoritative drug listing.
Therapeutic equivalence
TE code AB across rated presentations
An AB code is an A-rating: FDA considers the product therapeutically equivalent to pharmaceutical equivalents in the same Orange Book heading and equivalence group.
Patent & exclusivity record
No listed patents or exclusivity records
This means none appear for this application in the current Orange Book files. It is not a freedom-to-operate opinion and does not rule out unlisted patents, regulatory barriers, or product-specific rights.
Same-ingredient landscape
2 other ANDAs and 1 other NDA found
0 of the related ANDA applications are not marked discontinued. Sharing an ingredient does not establish pharmaceutical or therapeutic equivalence; strength, dosage form, route, and TE group still matter.
Which products are meaningfully comparable?
Exact ingredient + dosage form + route cohorts
ANDA 073652 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.
Capsule · Oral
Nitrofurantoin, Macrocrystalline
- Product rows
- 33
- Active applications
- 9
- Active with AB row
- 9
Why are clinical sections unavailable?
Exact application-label matching status
Exact source match queuedQueue ANDA-073652
No exact application-level FDA or DailyMed label match has been reviewed for this application. Approved uses, dosing, warnings, adverse reactions, and clinical evidence remain unavailable rather than being inherited from a related brand, generic, or ingredient record.
Until an exact application match passes human review, this page intentionally omits approved uses, dosing, warnings, adverse reactions, mechanism, and clinical-study summaries. It never inherits those claims from an RLD, brand, generic, or same-ingredient product.
Product detail
ANDA 073652
TE AB
- Strength
- 100MG
- Dosage form
- CAPSULE
- Route
- ORAL
- Marketing status
- Prescription
Key dates
Approval, patents, exclusivityApproval
FDA approval date of this drug product.
34 yr ago
Today
Pharmaceutical detail
FDA product recordActive ingredient
NITROFURANTOIN, MACROCRYSTALLINE
Strength
100MG
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
ANDA 073652
Product number
001
Marketing status
Prescription
Reference listed drug (RLD)
No
Reference standard (RS)
No
Listed patents
Orange Book patent fileNo patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Other FDA applications for Nitrofurantoin
28 additional filings · 28 generic
The FDA has approved 29 separate applications under this product name. Each row is one application: a distinct applicant and approval for the same drug.
| Application | Applicant | Approved | Strengths | TE code | Status |
|---|---|---|---|---|---|
| ANDA 073671 | Impax Labs Inc | Jan 28, 1993 | 1 | AB | Prescription |
| ANDA 073696 | Watson Labs | Dec 31, 1992 | 3 | — | Discontinued |
| ANDA 074336 | Pom Pharma | Jan 25, 1995 | 3 | — | Discontinued |
| ANDA 074967 | Aurobindo Pharma USA | Jul 09, 1997 | 2 | AB | Prescription |
| ANDA 077025 | Aurobindo Pharma USA | Oct 02, 2024 | 2 | AB | Prescription |
| ANDA 080003 | Elkins Sinn | Approved Prior to Jan 1, 1982 | 2 | — | Discontinued |
| ANDA 080043 | Sandoz | Approved Prior to Jan 1, 1982 | 2 | — | Discontinued |
| ANDA 080078 | Ivax Sub Teva Pharms | Approved Prior to Jan 1, 1982 | 2 | — | Discontinued |
| ANDA 080447 | Watson Labs | Approved Prior to Jan 1, 1982 | 2 | — | Discontinued |
| ANDA 084085 | Whiteworth Town Plsn | Approved Prior to Jan 1, 1982 | 1 | — | Discontinued |
| ANDA 084326 | Watson Labs | Approved Prior to Jan 1, 1982 | 2 | — | Discontinued |
| ANDA 085796 | Watson Labs | Approved Prior to Jan 1, 1982 | 1 | — | Discontinued |
| ANDA 085797 | Watson Labs | Approved Prior to Jan 1, 1982 | 1 | — | Discontinued |
| ANDA 091095 | Actavis Labs Fl Inc | Jun 18, 2015 | 3 | — | Discontinued |
| ANDA 201355 | Strides Pharma | Aug 14, 2013 | 1 | AB | Prescription |
| ANDA 201679 | Amneal Pharms | May 11, 2011 | 1 | — | Discontinued |
| ANDA 201693 | Novel Labs Inc | Sep 08, 2014 | 1 | AB | Prescription |
| ANDA 201722 | Sun Pharm Industries | Feb 16, 2016 | 3 | — | Discontinued |
| ANDA 203233 | Novel Labs Inc | Jul 09, 2018 | 2 | AB | Prescription |
| ANDA 205005 | Zydus Pharms | Dec 12, 2017 | 2 | AB | Prescription |
| ANDA 205180 | Actavis Mid Atlantic | May 03, 2016 | 1 | AB | Prescription |
| ANDA 208909 | Somerset Theraps LLC | Jan 14, 2025 | 1 | AB | Prescription |
| ANDA 211935 | Alembic | Jun 25, 2021 | 3 | AB | Prescription |
| ANDA 212607 | Aurobindo Pharma | May 11, 2023 | 1 | AB | Prescription |
| ANDA 216385 | Novitium Pharma | Apr 14, 2023 | 1 | AB | Prescription |
| ANDA 217272 | Mankind Pharma | Mar 21, 2023 | 3 | AB | Prescription |
| ANDA 218346 | Biocon Pharma | Oct 28, 2024 | 1 | AB | Prescription |
| ANDA 219495 | Annora Pharma | Jul 02, 2025 | 1 | AB | Prescription |
Active-ingredient family
Brand + generics
How to use this record responsibly
Scope, limitations, and primary sources
What to verify before making a decision
- The applicant is the holder of legal responsibility for the application; the Orange Book does not establish that the applicant manufactured or currently markets every listed product.
- RX, OTC, and discontinued are FDA listing categories, not real-time pharmacy inventory or commercial-availability data.
- Therapeutic equivalence applies only within the matching ingredient, dosage form, route, strength, and TE-code group; same ingredient alone is insufficient.
- Listed patent and exclusivity dates are regulatory intelligence, not legal advice, a freedom-to-operate analysis, or a reliable generic-launch forecast.
- The Orange Book is not prescribing information and does not provide indications, dosing, contraindications, adverse reactions, recalls, or current safety communications.
Official FDA references
- Electronic Orange Book record
- Orange Book preface and TE-code policy
- FDA product, patent, and exclusivity data files
Data shown here is normalized for search and comparison. When a regulatory, substitution, launch, or legal decision turns on a field, verify it against the current FDA record and the relevant source document.
Nitrofurantoin: frequently asked questions
Approval, therapeutic equivalence, patents, and exclusivity for this drug, from the FDA Orange Book.
Built directly from the FDA Orange Book product, patent, and exclusivity files refreshed Jul 02, 2026, 06:34 PM. Every strength of ANDA 073652 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.
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