Application 209357
- Type
- ANDA
- Sponsor
- MSN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PREGABALIN | PREGABALIN | CAPSULE;ORAL | 25MG | No | No |
| 002 | PREGABALIN | PREGABALIN | CAPSULE;ORAL | 50MG | No | No |
| 003 | PREGABALIN | PREGABALIN | CAPSULE;ORAL | 75MG | No | No |
| 004 | PREGABALIN | PREGABALIN | CAPSULE;ORAL | 100MG | No | No |
| 005 | PREGABALIN | PREGABALIN | CAPSULE;ORAL | 150MG | No | No |
| 006 | PREGABALIN | PREGABALIN | CAPSULE;ORAL | 200MG | No | No |
| 007 | PREGABALIN | PREGABALIN | CAPSULE;ORAL | 225MG | No | No |
| 008 | PREGABALIN | PREGABALIN | CAPSULE;ORAL | 300MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A209357-001 | PREGABALIN | PREGABALIN | 25MG | CAPSULE / ORAL | AB | 2019-07-19 | |
| A209357-002 | PREGABALIN | PREGABALIN | 50MG | CAPSULE / ORAL | AB | 2019-07-19 | |
| A209357-003 | PREGABALIN | PREGABALIN | 75MG | CAPSULE / ORAL | AB | 2019-07-19 | |
| A209357-004 | PREGABALIN | PREGABALIN | 100MG | CAPSULE / ORAL | AB | 2019-07-19 | |
| A209357-005 | PREGABALIN | PREGABALIN | 150MG | CAPSULE / ORAL | AB | 2019-07-19 | |
| A209357-006 | PREGABALIN | PREGABALIN | 200MG | CAPSULE / ORAL | AB | 2019-07-19 | |
| A209357-007 | PREGABALIN | PREGABALIN | 225MG | CAPSULE / ORAL | AB | 2019-07-19 | |
| A209357-008 | PREGABALIN | PREGABALIN | 300MG | CAPSULE / ORAL | AB | 2019-07-19 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A209357-001 | AB |
| A209357-002 | AB |
| A209357-003 | AB |
| A209357-004 | AB |
| A209357-005 | AB |
| A209357-006 | AB |
| A209357-007 | AB |
| A209357-008 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A209357-001 | PREGABALIN | 25MG | CAPSULE / ORAL | AB | 2019-07-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209357-002 | PREGABALIN | 50MG | CAPSULE / ORAL | AB | 2019-07-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209357-003 | PREGABALIN | 75MG | CAPSULE / ORAL | AB | 2019-07-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209357-004 | PREGABALIN | 100MG | CAPSULE / ORAL | AB | 2019-07-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209357-005 | PREGABALIN | 150MG | CAPSULE / ORAL | AB | 2019-07-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209357-006 | PREGABALIN | 200MG | CAPSULE / ORAL | AB | 2019-07-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209357-007 | PREGABALIN | 225MG | CAPSULE / ORAL | AB | 2019-07-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209357-008 | PREGABALIN | 300MG | CAPSULE / ORAL | AB | 2019-07-19 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209357-001 | PREGABALIN | 25MG | CAPSULE / ORAL | AB | 2019-07-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209357-002 | PREGABALIN | 50MG | CAPSULE / ORAL | AB | 2019-07-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209357-003 | PREGABALIN | 75MG | CAPSULE / ORAL | AB | 2019-07-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209357-004 | PREGABALIN | 100MG | CAPSULE / ORAL | AB | 2019-07-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209357-005 | PREGABALIN | 150MG | CAPSULE / ORAL | AB | 2019-07-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209357-006 | PREGABALIN | 200MG | CAPSULE / ORAL | AB | 2019-07-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209357-007 | PREGABALIN | 225MG | CAPSULE / ORAL | AB | 2019-07-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209357-008 | PREGABALIN | 300MG | CAPSULE / ORAL | AB | 2019-07-19 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209357-001 | PREGABALIN | 25MG | CAPSULE / ORAL | AB | 2019-07-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209357-002 | PREGABALIN | 50MG | CAPSULE / ORAL | AB | 2019-07-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209357-003 | PREGABALIN | 75MG | CAPSULE / ORAL | AB | 2019-07-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209357-004 | PREGABALIN | 100MG | CAPSULE / ORAL | AB | 2019-07-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209357-005 | PREGABALIN | 150MG | CAPSULE / ORAL | AB | 2019-07-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209357-006 | PREGABALIN | 200MG | CAPSULE / ORAL | AB | 2019-07-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209357-007 | PREGABALIN | 225MG | CAPSULE / ORAL | AB | 2019-07-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209357-008 | PREGABALIN | 300MG | CAPSULE / ORAL | AB | 2019-07-19 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209357-001 | PREGABALIN | 25MG | CAPSULE / ORAL | AB | 2019-07-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209357-002 | PREGABALIN | 50MG | CAPSULE / ORAL | AB | 2019-07-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209357-003 | PREGABALIN | 75MG | CAPSULE / ORAL | AB | 2019-07-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209357-004 | PREGABALIN | 100MG | CAPSULE / ORAL | AB | 2019-07-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209357-005 | PREGABALIN | 150MG | CAPSULE / ORAL | AB | 2019-07-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209357-006 | PREGABALIN | 200MG | CAPSULE / ORAL | AB | 2019-07-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209357-007 | PREGABALIN | 225MG | CAPSULE / ORAL | AB | 2019-07-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209357-008 | PREGABALIN | 300MG | CAPSULE / ORAL | AB | 2019-07-19 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209357-001 | PREGABALIN | 25MG | CAPSULE / ORAL | AB | 2019-07-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209357-002 | PREGABALIN | 50MG | CAPSULE / ORAL | AB | 2019-07-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209357-003 | PREGABALIN | 75MG | CAPSULE / ORAL | AB | 2019-07-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209357-004 | PREGABALIN | 100MG | CAPSULE / ORAL | AB | 2019-07-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209357-005 | PREGABALIN | 150MG | CAPSULE / ORAL | AB | 2019-07-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209357-006 | PREGABALIN | 200MG | CAPSULE / ORAL | AB | 2019-07-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209357-007 | PREGABALIN | 225MG | CAPSULE / ORAL | AB | 2019-07-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209357-008 | PREGABALIN | 300MG | CAPSULE / ORAL | AB | 2019-07-19 | b8a1b40f171c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A209357-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209357-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209357-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209357-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209357-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209357-006 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209357-007 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209357-008 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209357-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209357-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209357-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209357-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209357-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209357-006 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209357-007 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209357-008 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A209357-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209357-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209357-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209357-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209357-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209357-006 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209357-007 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209357-008 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209357-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209357-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209357-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209357-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209357-005 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209357-006 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209357-007 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209357-008 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209357-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209357-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209357-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209357-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209357-005 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209357-006 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209357-007 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209357-008 | AB | 1 | b8a1b40f171c… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Pregabalin | PREGABALIN | REMEDYREPACK INC. | f30a7a3b-d45e-4e0b-ab1b-1369b2f02320 | 2026-08-06 | Warnings, Adverse reactions | 209357 ANDA209357 70518-3345 |
| Pregabalin | PREGABALIN | REMEDYREPACK INC. | 326c643a-23c5-4dab-9266-abc22ca1f874 | 2026-08-06 | Warnings, Adverse reactions | 209357 ANDA209357 70518-3346 |
| Pregabalin | PREGABALIN | REMEDYREPACK INC. | 91edbe87-cd22-43a5-9952-1cd523b13820 | 2026-07-29 | Warnings, Adverse reactions | 209357 ANDA209357 70518-2763 |
| Pregabalin | PREGABALIN | REMEDYREPACK INC. | 14f3f9ba-7a4a-45d5-a25e-efe5cdff117d | 2026-07-28 | Warnings, Adverse reactions | 209357 ANDA209357 70518-2745 |
| Pregabalin | PREGABALIN | REMEDYREPACK INC. | 44ec2918-4e0c-4e2d-9157-81295a15df57 | 2026-07-28 | Warnings, Adverse reactions | 209357 ANDA209357 70518-2762 |
| Pregabalin | PREGABALIN | St. Mary's Medical Park Pharmacy | 36c3dda1-67fb-4dc5-e063-6294a90a1c3e | 2026-06-26 | Warnings, Adverse reactions | 209357 ANDA209357 |
| Pregabalin | PREGABALIN | St. Mary's Medical Park Pharmacy | 2e6e6f9c-a14c-2d75-e063-6294a90a827e | 2026-06-20 | Warnings, Adverse reactions | 209357 ANDA209357 |
| Pregabalin | PREGABALIN | REMEDYREPACK INC. | ba3006b7-991f-4ae0-b908-5910e827e5bf | 2026-06-12 | Warnings, Adverse reactions | 209357 ANDA209357 |
| Pregabalin | PREGABALIN | REMEDYREPACK INC. | 5290f7ad-6660-45ff-853d-6dcb947b570d | 2026-02-25 | Warnings, Adverse reactions | 209357 ANDA209357 70518-2525 |
| Pregabalin | PREGABALIN | ST. MARY'S MEDICAL PARK PHARMACY | 4b94bfc1-88fc-2b5f-e063-6394a90a7077 | 2026-02-24 | Warnings, Adverse reactions | 209357 ANDA209357 |
| Pregabalin | PREGABALIN | A-S Medication Solutions | 217c9f93-fe89-4684-8553-12ec9acaa507 | 2026-02-08 | Warnings, Adverse reactions | 209357 ANDA209357 |
| Pregabalin | PREGABALIN | A-S Medication Solutions | 5d33e9c7-6d81-485b-bf4a-9a588eda5208 | 2026-02-08 | Warnings, Adverse reactions | 209357 ANDA209357 |
| Pregabalin | PREGABALIN | A-S Medication Solutions | fa24fa02-e27d-476a-b6c4-93650aaaee68 | 2026-02-06 | Warnings, Adverse reactions | 209357 ANDA209357 50090-5071 |
| Pregabalin | PREGABALIN | Advanced Rx of Tennessee, LLC | afc89689-bea9-92ec-e053-2995a90a7f21 | 2025-11-17 | Warnings, Adverse reactions | 209357 ANDA209357 80425-0030 |
| Pregabalin | PREGABALIN | AvPAK | 40c0f658-2a0a-034b-e063-6394a90a1097 | 2025-10-09 | Warnings, Adverse reactions | 209357 ANDA209357 |
| Pregabalin | PREGABALIN | Proficient Rx LP | 7d25bec8-b503-4f63-8995-372a6df58c72 | 2025-10-01 | Warnings, Adverse reactions | 209357 ANDA209357 |
| Pregabalin | PREGABALIN | Novadoz Pharmaceuticals LLC | 193666f7-3c55-43b1-947a-2ffec40c687f | 2025-08-28 | Warnings, Adverse reactions | 209357 ANDA209357 72205-014 72205-011 72205-012 72205-016 72205-013 72205-017 72205-015 72205-018 |
| Pregabalin | PREGABALIN | Aphena Pharma Solutions - Tennessee, LLC | b1f4b888-ac88-4250-8db1-706e7cc01e93 | 2025-03-21 | Warnings, Adverse reactions | 209357 ANDA209357 |
| Pregabalin | PREGABALIN | Aphena Pharma Solutions - Tennessee, LLC | b0f34220-0657-4868-ae01-014f9300f622 | 2025-03-03 | Warnings, Adverse reactions | 209357 ANDA209357 |
| Pregabalin | PREGABALIN | Proficient Rx LP | 580955ba-86f6-4e86-b0fa-dd44e8828b0e | 2025-03-01 | Warnings, Adverse reactions | 209357 ANDA209357 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50090-5071 | Pregabalin | Pregabalin | A-S Medication Solutions | ANDA | Current |
| 50090-5071 | Pregabalin | Pregabalin | A-S Medication Solutions | ANDA | Current |
| 50090-5071 | Pregabalin | Pregabalin | A-S Medication Solutions | ANDA | Current |
| 69539-011 | Pregabalin | Pregabalin | MSN LABORATORIES PRIVATE LIMITED | ANDA | Current |
| 69539-011 | Pregabalin | Pregabalin | MSN LABORATORIES PRIVATE LIMITED | ANDA | Current |
| 69539-011 | Pregabalin | Pregabalin | MSN LABORATORIES PRIVATE LIMITED | ANDA | Current |
| 69539-012 | Pregabalin | Pregabalin | MSN LABORATORIES PRIVATE LIMITED | ANDA | Current |
| 69539-012 | Pregabalin | Pregabalin | MSN LABORATORIES PRIVATE LIMITED | ANDA | Current |
| 69539-012 | Pregabalin | Pregabalin | MSN LABORATORIES PRIVATE LIMITED | ANDA | Current |
| 69539-013 | Pregabalin | Pregabalin | MSN LABORATORIES PRIVATE LIMITED | ANDA | Current |
| 69539-013 | Pregabalin | Pregabalin | MSN LABORATORIES PRIVATE LIMITED | ANDA | Current |
| 69539-013 | Pregabalin | Pregabalin | MSN LABORATORIES PRIVATE LIMITED | ANDA | Current |
| 69539-014 | Pregabalin | Pregabalin | MSN LABORATORIES PRIVATE LIMITED | ANDA | Current |
| 69539-014 | Pregabalin | Pregabalin | MSN LABORATORIES PRIVATE LIMITED | ANDA | Current |
| 69539-014 | Pregabalin | Pregabalin | MSN LABORATORIES PRIVATE LIMITED | ANDA | Current |
| 69539-015 | Pregabalin | Pregabalin | MSN LABORATORIES PRIVATE LIMITED | ANDA | Current |
| 69539-015 | Pregabalin | Pregabalin | MSN LABORATORIES PRIVATE LIMITED | ANDA | Current |
| 69539-015 | Pregabalin | Pregabalin | MSN LABORATORIES PRIVATE LIMITED | ANDA | Current |
| 69539-016 | Pregabalin | Pregabalin | MSN LABORATORIES PRIVATE LIMITED | ANDA | Current |
| 69539-016 | Pregabalin | Pregabalin | MSN LABORATORIES PRIVATE LIMITED | ANDA | Current |
| 69539-016 | Pregabalin | Pregabalin | MSN LABORATORIES PRIVATE LIMITED | ANDA | Current |
| 69539-017 | Pregabalin | Pregabalin | MSN LABORATORIES PRIVATE LIMITED | ANDA | Current |
| 69539-017 | Pregabalin | Pregabalin | MSN LABORATORIES PRIVATE LIMITED | ANDA | Current |
| 69539-017 | Pregabalin | Pregabalin | MSN LABORATORIES PRIVATE LIMITED | ANDA | Current |
| 69539-018 | Pregabalin | Pregabalin | MSN LABORATORIES PRIVATE LIMITED | ANDA | Current |
| 69539-018 | Pregabalin | Pregabalin | MSN LABORATORIES PRIVATE LIMITED | ANDA | Current |
| 69539-018 | Pregabalin | Pregabalin | MSN LABORATORIES PRIVATE LIMITED | ANDA | Current |
| 70518-2525 | Pregabalin | Pregabalin | REMEDYREPACK INC. | ANDA | Current |
| 70518-2525 | Pregabalin | Pregabalin | REMEDYREPACK INC. | ANDA | Current |
| 70518-2525 | Pregabalin | Pregabalin | REMEDYREPACK INC. | ANDA | Current |
| 70518-2745 | Pregabalin | Pregabalin | REMEDYREPACK INC. | ANDA | Current |
| 70518-2745 | Pregabalin | Pregabalin | REMEDYREPACK INC. | ANDA | Current |
| 70518-2745 | Pregabalin | Pregabalin | REMEDYREPACK INC. | ANDA | Current |
| 70518-2745 | Pregabalin | Pregabalin | REMEDYREPACK INC. | ANDA | Current |
| 70518-2762 | Pregabalin | Pregabalin | REMEDYREPACK INC. | ANDA | Current |
| 70518-2762 | Pregabalin | Pregabalin | REMEDYREPACK INC. | ANDA | Current |
| 70518-2762 | Pregabalin | Pregabalin | REMEDYREPACK INC. | ANDA | Current |
| 70518-2763 | Pregabalin | Pregabalin | REMEDYREPACK INC. | ANDA | Current |
| 70518-2763 | Pregabalin | Pregabalin | REMEDYREPACK INC. | ANDA | Current |
| 70518-3345 | Pregabalin | Pregabalin | REMEDYREPACK INC. | ANDA | Current |
| 70518-3346 | Pregabalin | Pregabalin | REMEDYREPACK INC. | ANDA | Current |
| 70518-3346 | Pregabalin | Pregabalin | REMEDYREPACK INC. | ANDA | Current |
| 72205-011 | Pregabalin | Pregabalin | Novadoz Pharmaceuticals LLC | ANDA | Current |
| 72205-011 | Pregabalin | Pregabalin | Novadoz Pharmaceuticals LLC | ANDA | Current |
| 72205-011 | Pregabalin | Pregabalin | Novadoz Pharmaceuticals LLC | ANDA | Current |
| 72205-011 | Pregabalin | Pregabalin | Novadoz Pharmaceuticals LLC | ANDA | Current |
| 72205-012 | Pregabalin | Pregabalin | Novadoz Pharmaceuticals LLC | ANDA | Current |
| 72205-012 | Pregabalin | Pregabalin | Novadoz Pharmaceuticals LLC | ANDA | Current |
| 72205-012 | Pregabalin | Pregabalin | Novadoz Pharmaceuticals LLC | ANDA | Current |
| 72205-012 | Pregabalin | Pregabalin | Novadoz Pharmaceuticals LLC | ANDA | Current |
| 72205-013 | Pregabalin | Pregabalin | Novadoz Pharmaceuticals LLC | ANDA | Current |
| 72205-013 | Pregabalin | Pregabalin | Novadoz Pharmaceuticals LLC | ANDA | Current |
| 72205-013 | Pregabalin | Pregabalin | Novadoz Pharmaceuticals LLC | ANDA | Current |
| 72205-013 | Pregabalin | Pregabalin | Novadoz Pharmaceuticals LLC | ANDA | Current |
| 72205-014 | Pregabalin | Pregabalin | Novadoz Pharmaceuticals LLC | ANDA | Current |
| 72205-014 | Pregabalin | Pregabalin | Novadoz Pharmaceuticals LLC | ANDA | Current |
| 72205-014 | Pregabalin | Pregabalin | Novadoz Pharmaceuticals LLC | ANDA | Current |
| 72205-014 | Pregabalin | Pregabalin | Novadoz Pharmaceuticals LLC | ANDA | Current |
| 72205-015 | Pregabalin | Pregabalin | Novadoz Pharmaceuticals LLC | ANDA | Current |
| 72205-015 | Pregabalin | Pregabalin | Novadoz Pharmaceuticals LLC | ANDA | Current |
| 72205-015 | Pregabalin | Pregabalin | Novadoz Pharmaceuticals LLC | ANDA | Current |
| 72205-015 | Pregabalin | Pregabalin | Novadoz Pharmaceuticals LLC | ANDA | Current |
| 72205-016 | Pregabalin | Pregabalin | Novadoz Pharmaceuticals LLC | ANDA | Current |
| 72205-016 | Pregabalin | Pregabalin | Novadoz Pharmaceuticals LLC | ANDA | Current |
| 72205-016 | Pregabalin | Pregabalin | Novadoz Pharmaceuticals LLC | ANDA | Current |
| 72205-016 | Pregabalin | Pregabalin | Novadoz Pharmaceuticals LLC | ANDA | Current |
| 72205-017 | Pregabalin | Pregabalin | Novadoz Pharmaceuticals LLC | ANDA | Current |
| 72205-017 | Pregabalin | Pregabalin | Novadoz Pharmaceuticals LLC | ANDA | Current |
| 72205-017 | Pregabalin | Pregabalin | Novadoz Pharmaceuticals LLC | ANDA | Current |
| 72205-017 | Pregabalin | Pregabalin | Novadoz Pharmaceuticals LLC | ANDA | Current |
| 72205-018 | Pregabalin | Pregabalin | Novadoz Pharmaceuticals LLC | ANDA | Current |
| 72205-018 | Pregabalin | Pregabalin | Novadoz Pharmaceuticals LLC | ANDA | Current |
| 72205-018 | Pregabalin | Pregabalin | Novadoz Pharmaceuticals LLC | ANDA | Current |
| 72205-018 | Pregabalin | Pregabalin | Novadoz Pharmaceuticals LLC | ANDA | Current |
| 80425-0026 | Lyrica | Pregabalin 50mg | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0026 | Lyrica | Pregabalin 50mg | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0026 | Pregabalin | Pregabalin | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0026 | Pregabalin | Pregabalin | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0030 | Lyrica | Pregabalin 75mg | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0030 | Lyrica | Pregabalin 75mg | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |