Application 050442
- Type
- NDA
- Sponsor
- PFIZER
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VIBRAMYCIN | DOXYCYCLINE HYCLATE | INJECTABLE;INJECTION | EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | VIBRAMYCIN | DOXYCYCLINE HYCLATE | INJECTABLE;INJECTION | EQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N050442-001 | VIBRAMYCIN | DOXYCYCLINE HYCLATE | EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | ||
| N050442-002 | VIBRAMYCIN | DOXYCYCLINE HYCLATE | EQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N050442-001 | VIBRAMYCIN | EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N050442-002 | VIBRAMYCIN | EQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N050442-001 | VIBRAMYCIN | EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N050442-002 | VIBRAMYCIN | EQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N050442-001 | VIBRAMYCIN | EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N050442-002 | VIBRAMYCIN | EQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N050442-001 | VIBRAMYCIN | EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N050442-002 | VIBRAMYCIN | EQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N050442-001 | VIBRAMYCIN | EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 5aa47cf7b7d7… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N050442-002 | VIBRAMYCIN | EQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N050442-001 | VIBRAMYCIN | EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N050442-002 | VIBRAMYCIN | EQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N050442-001 | VIBRAMYCIN | EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N050442-002 | VIBRAMYCIN | EQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N050442-001 | VIBRAMYCIN | EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N050442-002 | VIBRAMYCIN | EQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N050442-001 | VIBRAMYCIN | EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N050442-002 | VIBRAMYCIN | EQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N050442-001 | VIBRAMYCIN | EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N050442-002 | VIBRAMYCIN | EQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N050442-001 | VIBRAMYCIN | EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 6a51e52b5d6a… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N050442-002 | VIBRAMYCIN | EQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | N050442-001 | VIBRAMYCIN | EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 1c564ffb4f44… | ||
| 2024-02-18 07:12 UTC | 2024-02 | N050442-002 | VIBRAMYCIN | EQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | N050442-001 | VIBRAMYCIN | EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | ea1830bbd6c7… | ||
| 2023-12-20 04:57 UTC | 2023-12 | N050442-002 | VIBRAMYCIN | EQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N050442-001 | VIBRAMYCIN | EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | a72a2bbeb626… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N050442-002 | VIBRAMYCIN | EQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N050442-001 | VIBRAMYCIN | EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 9b2671bbb829… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N050442-002 | VIBRAMYCIN | EQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N050442-001 | VIBRAMYCIN | EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | a67488948f0b… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N050442-002 | VIBRAMYCIN | EQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N050442-001 | VIBRAMYCIN | EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 3f0d92c62455… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N050442-002 | VIBRAMYCIN | EQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | N050442-001 | VIBRAMYCIN | EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 053a50430f4f… | ||
| 2023-05-13 08:27 UTC | 2023-05 | N050442-002 | VIBRAMYCIN | EQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | N050442-001 | VIBRAMYCIN | EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 3bdfa0b2c4d7… | ||
| 2023-01-26 05:58 UTC | 2023-01 | N050442-002 | VIBRAMYCIN | EQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N050442-001 | VIBRAMYCIN | EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 3a93d1ddd44b… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N050442-002 | VIBRAMYCIN | EQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 3a93d1ddd44b… |
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 |
|---|---|---|---|---|---|---|
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | REMEDYREPACK INC. | 051654c7-8ba6-44f2-842c-72f515e9b32d | 2026-09-15 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| doxycycline hyclate | DOXYCYCLINE HYCLATE | HAWAII REPACK, INC | 88c429a1-351d-432e-b69b-d7a0afca482a | 2026-09-09 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | A-S Medication Solutions | 9ecadbc8-3087-4692-916a-b7f392d8e8da | 2026-09-09 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | REMEDYREPACK INC. | 5fdc01c3-c62f-40cf-8351-91cbcc43d379 | 2026-09-01 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline hyclate | DOXYCYCLINE HYCLATE | REMEDYREPACK INC. | df44c686-de34-487a-8741-a0a12993cab2 | 2026-08-27 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline | DOXYCYCLINE HYCLATE | REMEDYREPACK INC. | 2c29f716-bdb0-437d-92a4-d856b87db976 | 2026-08-26 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | NuCare Pharmaceuticals,Inc. | 0106a3d3-db4d-f6ee-e063-6294a90a25e9 | 2026-08-26 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline | DOXYCYCLINE HYCLATE | Acella Pharmaceuticals, LLC | 3fb9f5ad-90a2-4858-bc34-f800d8b2fa90 | 2026-08-18 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | Major Pharmaceuticals | e7c14a8e-c713-4f03-94e8-1ec9ae077d4d | 2026-08-05 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | REMEDYREPACK INC. | 2305ab4a-7d08-41f6-9c39-c9b6835be389 | 2026-08-05 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline | DOXYCYCLINE HYCLATE | REMEDYREPACK INC. | db53637e-16ac-41b0-b9d5-553471405d64 | 2026-08-03 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | PD-Rx Pharmaceuticals, Inc. | cf95b2ca-2cf8-49a8-8e3a-f9b0f5b2072c | 2026-07-29 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | PD-Rx Pharmaceuticals, Inc. | 3af9348c-a98b-4059-a5ef-4229e2b33af0 | 2026-07-20 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | PD-Rx Pharmaceuticals, Inc. | 0994d23a-f9e4-4c33-ba44-a1f4ae4a312c | 2026-07-20 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | PD-Rx Pharmaceuticals, Inc. | 1401d590-0967-4c6b-b52b-a83e9f6df097 | 2026-07-17 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | PD-Rx Pharmaceuticals, Inc. | b988f851-cc06-4570-9706-cf65d370bd8e | 2026-07-17 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | PD-Rx Pharmaceuticals, Inc. | 35aa295e-ff1b-453b-8eeb-65bbeda3baa5 | 2026-07-17 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycyclate Hyclate | DOXYCYCLINE HYCLATE | REMEDYREPACK INC. | 4dc319c1-b7ef-40e4-9e66-fb24cfdefea8 | 2026-07-09 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | REMEDYREPACK INC. | 6e3d0691-c071-441c-9b00-22a380305066 | 2026-07-03 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | Chartwell RX, LLC | fad03768-f1d2-459f-965e-0ec29f189f1f | 2026-06-30 | Warnings, Adverse reactions | DOXYCYCLINE HYCLATE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.